Anti-obesity Effect of Koji-extracted Beverage Fermented With Pediococcus Pentosaceus LP28

Not Applicable

Completed

• Conditions: Overweight
• Interventions: Dietary Supplement: Koji-extracted beverage fermented with Pediococcus pentosaceus LP28; Dietary Supplement: Placebo

• Registration Number: NCT02050555
• Lead Sponsor: Hiroshima University

Brief Summary

This study is designed to evaluate the effect of koji-extracted beverage fermented with Pediococcus pentosaceus LP28 on BMI and body fat in overweight subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-01-29
• Study First Submitted QC: 2014-01-29
• Study First Posted: 2014-01-30
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-07
• Last Update Posted: 2014-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• BMI 25-30 kg/m2

Exclusion Criteria

• Taking drugs or functional food that may affect body weight or body fat
• Pregnant or nursing a child
• Participation in any clinical trial within 90 days of the commencement of the trial
• Renal or hepatic dysfunction
• Heart disease
• History of severe disease and/or major surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Koji-extracted beverage fermented with LP28	Koji-extracted beverage fermented with Pediococcus pentosaceus LP28	100ml/day for 12 weeks. 1x10\^11 cells (LP28)/day
Koji-extracted beverage	Placebo	100ml/day for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change in BMI from baseline	Every 4 weeks (Overall 12 weeks)
Change in body fat mass (percentage) from baseline	Every 4 weeks (Overall 12 weeks)

Secondary Outcome Measures

Name	Time	Method
Change in fasting plasma glucose from baseline	Every 4 weeks (Overall 12 weeks)
Change in serum total cholesterol from baseline	Every 4 weeks (Overall 12 weeks)
Change in homeostasis model assessment-insulin resistance (HOMA-R) from baseline	Weeks 0 and 12	HOMA-R is calculated as fasting insulin (mU/mL) x fasting glucose (mg/dL) / 405
Change in abdominal circumference from baseline	Every 4 weeks (Overall 12 weeks)
Change in visceral fat area by CT scan from baseline	Weeks 0 and 12
Change in 2h glucose concentration after the oral glucose tolerance test (OGTT) from baseline	Weeks 0 and 12
Change in serum triglyceride from baseline	Every 4 weeks (Overall 12 weeks)
Change in fasting insulin from baseline	Weeks 0 and 12
Change in serum LDL cholesterol from baseline	Every 4 weeks (Overall 12 weeks)
Change in serum HDL cholesterol from baseline	Every 4 weeks (Overall 12 weeks)

Trial Locations

Locations (1)

Hiroshima University; 🇯🇵 Hiroshima, Japan